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510(k) K981124

ACCUDEXA BONE DENSITOMETER by Schick Technologies, Inc. — Product Code KGI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 4, 1998
Date Received
March 27, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Densitometer, Bone
Device Class
Class II
Regulation Number
892.1170
Review Panel
RA
Submission Type

Other clearances by Schick Technologies, Inc.

  • K110768 — COMPUTED DENTAL RADIOGRAPHY (April 20, 2011)
  • K093453 — MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEM (November 30, 2009)
  • K072134 — SCHICK COMPUTED ORAL RADIOLOGY SYSTEM (November 2, 2007)
  • K053558 — CEPH, MODEL 4900 (February 17, 2006)
  • K041385 — MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEM (June 7, 2004)
  • K031291 — CDR PANX, MODEL 4792 (May 5, 2003)
  • K022953 — MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEM (October 2, 2002)
  • K001429 — MODIFICATION TO ACCUDEXA BONE DENSITOMETER (May 26, 2000)
  • K982661 — CDR - PAN MODEL 4700 (December 11, 1998)
  • K971735 — ACCUDEXA BONE DENSITOMETER (December 2, 1997)

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  • K220402 — VirtuOst (May 19, 2023)
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  • K213760 — ABMD Software (July 29, 2022)
  • K191112 — GEHC DXA Bone Densitometers with enCORE version 18 (September 19, 2019)
  • K180782 — Aria (April 20, 2018)
  • K161682 — GE Lunar DXA Bone Densitometers with enCORE version 17 (December 2, 2016)
  • K152299 — TBS iNsight (April 29, 2016)